FDA’s Over-the-Counter Clearance for AliveCor Heart Monitor

Telemonitoring has taken a step forward in the U.S. with the news that the FDA has granted AliveCor, Inc., over-the-counter (OTC) clearance for the AliveCor™ Heart Monitor. The device is a single-channel ECG (electrocardiogram) recorder, previously cleared for issue by prescription only, now available for pre-order purchase, with shipments beginning in March.

Background

The AliveCor Heart Monitor provides people with suspected or diagnosed heart conditions, and those at risk of heart conditions, the ability to track their heart health anytime, anywhere, at an affordable cost.

Health professionals and patients can use the device to detect, monitor and analyze irregular heart rhythms. The AliveCor Heart Monitor’s medical grade ECG recordings can be shared directly with a user’s physician, or sent to a U.S. board-certified cardiologist or a U.S. based cardiac technician through AliveInsights™, an analysis service that offers expert review of ECGs directly through the free AliveECG app. Recordings are then reviewed and analyzed providing users with a more complete picture of their current heart health.

The AliveCor Heart Monitor is the only FDA cleared mobile ECG recorder that supports both iPhone and Android smartphones. It records, displays, stores, and transfers single-channel ECG rhythms wirelessly, using the free AliveECG app. With secure storage in the cloud, users can access their data confidentially anytime, anywhere, and can grant access to their physician. The Heart Monitor is available for purchase in the U.S. by health professionals, patients with prescriptions and now over-the-counter.

Company comments

“Over-the-counter access to mobile health devices has the potential to change the way consumers manage their overall health, facilitate preventative medical care and save both patients and healthcare professionals time,” said Euan Thomson, president and chief executive officer of AliveCor. “We are pleased to now provide easier access to our innovative Heart Monitor and with the help of healthcare professionals provide timely analysis of data to all users.”

Source: AliveCor, Inc., Business Wire

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